Combined Ablation Techniques for Ventricular Tachycardia

(DUAL-VT Trial)

Recruiting at 2 trial locations

Overseen By Atul Verma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Heart failure, Myocardial infarction, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment Combined Pulsed Field and Radiofrequency Energy for Ventricular Tachycardia?

Research shows that radiofrequency energy is effective in treating certain types of ventricular tachycardia, with success rates over 80% in some cases. Pulsed-field ablation, while newer, has shown promise in treating large areas quickly and safely, although it may not be as effective for deeper heart tissue. ^{1 2 3 4 5}

Is the combined ablation technique for ventricular tachycardia safe?

The combined ablation technique, using pulsed-field and radiofrequency energy, has been used safely in humans, but there are some risks. Complications can occur in 5-7% of cases, with severe complications in 3-4% of patients, especially those with severe heart disease. Radiation exposure during the procedure also carries a small risk of cancer and genetic issues. ^{3 5 6 7 8}

How does the Combined Pulsed Field and Radiofrequency Energy treatment for ventricular tachycardia differ from other treatments?

The Combined Pulsed Field and Radiofrequency Energy treatment for ventricular tachycardia is unique because it uses a combination of pulsed-field ablation, which targets areas with poor stability quickly and with a large scope, and radiofrequency energy, which allows for precise energy delivery to specific areas. This combination aims to improve the effectiveness and safety of treating large diseased areas in the heart compared to traditional methods. ^{2 3 4 5 9}

What is the purpose of this trial?

This will be a single arm study evaluating a new ablation technology for performing catheter ablation of ventricular tachycardia. The technology combines novel pulsed field ablation with radiofrequency ablation.

Research Team

Atul Verma, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

This trial is for individuals with types of abnormal heart rhythms known as nonsustained ventricular tachycardia and ventricular tachycardia. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and may be required to meet certain health standards.

Inclusion Criteria

My heart's pumping ability is at least 30%.

Documented episodes assessment will be performed by a review of ECGs, hospitalization records, and/or Implantable Cardioverter Defibrillator (ICD) interrogation

Patients must have an ICD implanted

Exclusion Criteria

I am scheduled for a special heart mapping or treatment before my VT procedure.

I had a heart attack less than 2 months ago, but if I have ongoing VT, it's been at least 3 weeks.

I do not have tubes inserted into my heart chambers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation of ventricular tachycardia using a novel combination ablation device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Combined Pulsed Field and Radiofrequency Energy

Trial Overview The study is testing a new ablation technology that uses both pulsed field ablation and radiofrequency energy to treat irregular heartbeats in the lower chambers of the heart. It's a single-arm study, meaning all participants will receive this combined treatment approach.

Participant Groups

Group I: Ablation group Experimental Treatment 1 Intervention

Patients in this single arm will all undergo clinically-indicated catheter ablation of ventricular tachycardia using a novel combination ablation device capable of delivering both radiofrequency and pulsed field ablation.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[High frequency current catheter ablation in ventricular tachycardia]. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

Catheter ablation of ventricular tachycardia using radiofrequency current. [2012]

3. Italy pubmed.ncbi.nlm.nih.gov

[The transcatheter ablation of arrhythmias]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Ablation of ventricular fibrillation and tachycardia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Case Series of Ventricular Tachycardia Ablation With Pulsed-Field Ablation: Pushing Technology Further (Into the Ventricle). [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pulsed field ablation: a promise that came true. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Complications and risk of high frequency catheter ablation of tachycardiac arrhythmias]. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency catheter ablation as a cure for idiopathic tachycardia of both left and right ventricular origin. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

High-energy catheter ablation of cardiac arrhythmias: an outmoded technique in the 1990s. [2019]